Mel vs BUCY+VP-16 Conditioning Regimen for MM Undergoing Auto-HSCT

Sponsor

Nanfang Hospital of Southern Medical University (Other)

Overall Status

Unknown status

CT.gov ID

NCT03385096

Collaborator

Guangzhou First People's Hospital (Other), Zhujiang Hospital (Other), Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University (Other), Third Affiliated Hospital, Sun Yat-Sen University (Other)

122

Enrollment

Location

Arms

46.9

Anticipated Duration (Months)

2.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of Melphalan and BUCY+VP-16 myeloablative conditioning regimens in multiple myeloma undergoing autologous hematopoietic stem cell transplantation.

Condition or Disease	Intervention/Treatment	Phase
Autologous Hematopoietic Stem Cell Transplantation Conditioning Multiple Myeloma	Drug: Busulfan (BU) Drug: Cyclophosphamide (CY) Drug: Etoposide (VP-16) Drug: Melphalan	Phase 2/Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

122 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Melphalan vs Busulfan+ Cyclophosphamide+ Etoposide Conditioning Regimen for Multiple Myeloma Undergoing Autologous Hematopoietic Stem Cell Transplantation

Actual Study Start Date :

Jan 2, 2018

Anticipated Primary Completion Date :

Dec 1, 2020

Anticipated Study Completion Date :

Dec 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: BUCY+VP-16 For MM patients undergoing auto-HSCT，BUCY+VP-16 conditioning regimen was BU 3.2 mg/kg/day on days -8 and -6；CY 60 mg/kg/day on days -5 and -4; VP-16 10mg/kg/day on days -3 and -2.	Drug: Busulfan (BU) Busulfan was administered at 3.2 mg/kg/day on days -8 to -6. -7 to -4. Drug: Cyclophosphamide (CY) Cyclophosphamide was administered at 60 mg/kg/day on days -5 to -4. on days -3 to -2. Drug: Etoposide (VP-16) Etoposide was administered at 10 mg/kg/day on days -3 to -2. -3 to -2.
Active Comparator: Melphalan For MM patients undergoing auto-HSCT，Melphalan conditioning regimen was Melphalan 200mg/m2 on day -2.	Drug: Melphalan Melphalan was administered at 200mg/m2 on day -2.

Arm

Intervention/Treatment

Experimental: BUCY+VP-16

For MM patients undergoing auto-HSCT，BUCY+VP-16 conditioning regimen was BU 3.2 mg/kg/day on days -8 and -6；CY 60 mg/kg/day on days -5 and -4; VP-16 10mg/kg/day on days -3 and -2.

Drug: Busulfan (BU)

Busulfan was administered at 3.2 mg/kg/day on days -8 to -6. -7 to -4.

Drug: Cyclophosphamide (CY)

Cyclophosphamide was administered at 60 mg/kg/day on days -5 to -4. on days -3 to -2.

Drug: Etoposide (VP-16)

Etoposide was administered at 10 mg/kg/day on days -3 to -2. -3 to -2.

Active Comparator: Melphalan

For MM patients undergoing auto-HSCT，Melphalan conditioning regimen was Melphalan 200mg/m2 on day -2.

Drug: Melphalan

Melphalan was administered at 200mg/m2 on day -2.

Outcome Measures

Primary Outcome Measures

OS [3 year]
overall survival (OS)

Secondary Outcome Measures

relapse rate relapse rate [3 year]
relapse rate
DFS [3 year]
disease-free survival (DFS)
TRM [3 year]
transplant-related mortality (TRM)

Eligibility Criteria

Criteria

Ages Eligible for Study:

14 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Multiple Myeloma patients
Achieving at least VGPR after chemotherapy, then mobilizing and collecting of peripheral blood stem cells

Exclusion Criteria:

Any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure)
Patients with any conditions not suitable for the trial (investigators' decision